Job Description Regulatory Affairs Executive

Position Details

Job Title: Regulatory Affairs Executive
Department: Regulatory Affairs
Industry: Nutraceutical / Healthcare
Reports To: Managing Director / Head – Regulatory Affairs
Location: Mallapur, Hyderabad
Employment Type: Full-time

Job Purpose

To manage and support regulatory activities for nutraaceutical products in international markets, ensuring timely preparation, submission, maintenance, and compliance of regulatory dossiers in accordance with applicable country-specific regulations and global regulatory requirements.

Key Responsibilities

1. Regulatory Submissions

- Prepare, compile, review, and coordinate regulatory dossiers for nutraceutical products for international markets.
- Support preparation and submission of CTD/eCTD and country-specific dossiers as applicable.
- Coordinate preparation of registration documents, application forms, administrative documents, product information, declarations, and supporting documents.
- Ensure submissions are complete, accurate, compliant, and submitted within agreed timelines.
- Track submission status and maintain regulatory submission records.

2. Regulatory Compliance

- Monitor and interpret applicable regulatory guidelines and requirements for assigned countries/markets.
- Ensure regulatory activities comply with applicable requirements of agencies such as US FDA, EMA, MHRA, TGA, Health Canada, GCC, ASEAN, African regulatory authorities, and other relevant health authorities, as applicable.
- Support regulatory impact assessments for changes to products, manufacturing processes, specifications, analytical methods, packaging materials, sites, and suppliers.
- Maintain awareness of changes in regulatory guidelines and communicate their impact to relevant departments.

3. Post-Approval Regulatory Activities

- Coordinate variations, renewals, amendments, extensions, and other post-approval regulatory submissions.
- Maintain product registrations and ensure timely renewal of marketing authorizations.
- Support implementation of approved regulatory changes.
- Maintain regulatory databases, trackers, product registration status, and approval records.
- Coordinate responses to regulatory authority queries and deficiency letters.

4. Cross-Functional Coordination

- Coordinate with Quality Assurance, Quality Control, R&D;, Production, Analytical Development, Packaging, Supply Chain, Pharmacovigilance, and Business Development teams for regulatory requirements.
- Obtain technical and supporting documents required for regulatory submissions.
- Review technical documents for regulatory completeness and consistency.




- Follow up with internal stakeholders to ensure regulatory deliverables are completed on time.

5. Regulatory Authority Communication

- Support communication with regulatory consultants, agents, distributors, and regulatory authorities, as applicable.
- Prepare responses to regulatory queries in coordination with relevant technical departments.
- Maintain records of regulatory correspondence and commitments.
- Track commitments and ensure timely closure of regulatory actions.

6. Product Registration & Export Documentation

- Support registration and maintenance of nutraceutical products in export markets.
- Review Certificates of Nutraaceutical Product (CPP), Free Sale Certificates, GMP certificates, manufacturing licenses, product certificates, and other regulatory documents as required.
- Coordinate legalization, notarization, apostille, consular attestation, and other document requirements where applicable.
- Ensure regulatory documents required for exports are current and available.

7. Regulatory Intelligence

- Monitor changes in regulatory guidelines, country-specific requirements, and registration procedures.
- Conduct regulatory research for current markets and products.
- Maintain a database of country-specific regulatory requirements.
- Provide regulatory inputs for new product development, product launches, and market expansion.

8. Documentation & Quality Systems

- Maintain accurate and controlled regulatory documentation.
- Ensure compliance with applicable SOPs, document-control procedures, and quality-system requirements.
- Participate in internal audits, regulatory inspections, and compliance activities when required.
- Support continuous improvement of regulatory processes and documentation systems.

Key Performance Indicators (KPIs)

- Timely and accurate submission of regulatory dossiers.
- Percentage of submissions accepted without major deficiencies.
- Timely responses to regulatory authority queries.
- On-time renewal and maintenance of product registrations.
- Accuracy and completeness of regulatory documentation.
- Timely implementation of approved variations and regulatory changes.
- Effective coordination with internal and external stakeholders.
- Compliance with applicable regulatory requirements and company SOPs.

Education & Qualification

Essential:

- Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences, or a related field.




- Knowledge of pharmaceutical regulatory affairs and documentation.

Preferred:

- M.Pharm / Pharm.D / MSc / equivalent qualification.
- Certification or specialized training in Regulatory Affairs is an advantage.

Experience

- 2–5 years of relevant experience in pharmaceutical regulatory affairs, preferably in an export-oriented pharmaceutical manufacturing company.
- Experience in international product registrations, CTD/eCTD dossiers, variations, renewals, and regulatory query responses is preferred.
- Exposure to regulated and/or emerging markets will be an advantage.

Technical Skills

- Good understanding of CTD/eCTD dossier structure.
- Knowledge of pharmaceutical regulatory guidelines and registration procedures.
- Understanding of pharmaceutical manufacturing, analytical, quality, and stability documentation.
- Familiarity with regulatory databases and document-management systems.
- Good knowledge of Microsoft Office, particularly Word, Excel, and PowerPoint.
- Ability to review documents for consistency, completeness, and regulatory compliance.

Behavioral Competencies

- Strong attention to detail.
- Good written and verbal communication skills.
- Strong documentation and organizational skills.
- Ability to manage multiple projects and deadlines.
- Effective cross-functional coordination.
- Analytical and problem-solving ability.
- Proactive approach and willingness to learn.
- Ability to work independently as well as in a team.
- High level of integrity and commitment to regulatory compliance.

Key Interfaces

Internal:
Regulatory Affairs, Quality Assurance, Quality Control, R&D;, Production, Analytical Development, Packaging, Supply Chain, Pharmacovigilance, Business Development, and Management.

External:
Regulatory Authorities, Regulatory Consultants, Local Agents, Distributors, Contract Organizations, and other regulatory service providers.

Working Conditions

The role involves regular coordination with internal and external stakeholders and may require working across different time zones to support international markets. Occasional travel may be required for regulatory meetings, audits, inspections, or business requirements.

Ideal Candidate Profile

The ideal candidate should have strong pharmaceutical regulatory knowledge, excellent documentation skills, attention to detail, and practical exposure to international regulatory submissions and product registrations. The candidate should be capable of coordinating with multiple departments and managing regulatory activities within defined timelines while maintaining a high standard of compliance.

Mail : [email protected]

Mobile : (phone hidden)

📌 Regulatory Affairs Executive (Hyderabad)
🏢 Lactonova Nutripharm
📍 Hyderabad